FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GLUCOSCAN METER MODEL II
K Number: K822699
·
Decision Nov 5, 1982
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
400
Applicant Total
42
Review Days
59
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Basic Information
- Device Name
- GLUCOSCAN METER MODEL II
- K Number
- K822699
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Lifescan, Inc.
- Date Received
- September 7, 1982
- Decision Date
- November 5, 1982
- Product Code
- CGA
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | FDA class 2 | Clinical Chemistry |
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|---|---|---|---|
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| K093745 | ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM | Feb 11, 2011 | Substantially Equivalent |
| K082590 | SYMPHONY METER REMOTE | Dec 17, 2008 | Substantially Equivalent |
| K082513 | ONETOUCH VITA BLOOD GLUCOSE MONITORING SYSTEM | Oct 22, 2008 | Substantially Equivalent |
| K081318 | ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM | Jun 9, 2008 | Substantially Equivalent |
| K073231 | ONETOUCH ULTRALINK BLOOD GLUCOSE MONITORING SYSTEM | Apr 18, 2008 | Substantially Equivalent |
| K072543 | ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEM | Oct 5, 2007 | Substantially Equivalent |
| K062195 | MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM | Aug 16, 2006 | Substantially Equivalent |
| K061118 | ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEM | May 19, 2006 | Substantially Equivalent |